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EVS-EN ISO 10993-5:2009+A11:2025

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

General information

Valid from 02.06.2025
Base Documents
ISO 10993-5:2009; EN ISO 10993-5:2009; EN ISO 10993-5:2009/A11:2025
Directives or regulations
None

Standard history

Status
Date
Type
Name
02.06.2025
Main + amendment
15.05.2025
Amendment
07.08.2009
Main
This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices.
These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion.
These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

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